MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	07P72-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely decreased alinity c carbon dioxide result for one patient with a history of igg k paraprotein.The following data was provided: sample id (b)(6) initial result, on (b)(6) 2025 with serial number (b)(6) and lot number 67438uq12, was 14, result using radiometer blood gas was 28 mmol/l.Sample id (b)(6) initial result, on (b)(6) 2024 with serial number (b)(6) and lot number 66500uq06, was 17, repeat, on radiometer, was 25.4 mmol/l.The customer performed dilution studies which were inconclusive.The customer performed peg studies which showed 167% and the control patient used had 97% recovery.The sample was also tested on the gem and the result was 27.The patient¿s previous results were provided: (b)(6) 2025, at a different site, result was 12 mmol/l; (b)(6) 2024, at a different site, result was 12 mmol/l; (b)(6) 2010 result with a roche assay was 8, repeat, on the gem, was 27.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased patient results when using alinity c carbon dioxide, lot numbers 67438uq12 and lot 66500uq06, included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed, as returns were not available.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Manufacturing documentation for the likely cause lots was reviewed and did not identify any issues.Device history record review on lot numbers 67438uq12 and lot 66500uq06 did not identify any non-conformances or deviations with the likely cause lots.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity c carbon dioxide, lot numbers 67438uq12 and lot 66500uq06, was identified.
Event or Problem Description
The customer observed a falsely decreased alinity c carbon dioxide result for one patient with a history of igg k paraprotein.The following data was provided: sample id (b)(6) initial result, on 13may2025 with serial number (b)(6) and lot number 67438uq12, was 14, result using radiometer blood gas was 28 mmol/l.Sample id (b)(6) initial result, on 20nov2024 with serial number ac01718 and lot number 66500uq06, was 17, repeat, on radiometer, was 25.4 mmol/l.The customer performed dilution studies which were inconclusive.The customer performed peg studies which showed 167% and the control patient used had 97% recovery.The sample was also tested on the gem and the result was 27.The patient¿s previous results were provided: 23jan2025, at a different site, result was 12 mmol/l; 02nov2024, at a different site, result was 12 mmol/l; 21jan2010 result with a roche assay was 8, repeat, on the gem, was 27.There was no impact to patient management reported.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22187569
• Report Number: 3002809144-2025-00184
• Device Sequence Number: 8691097
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)250731(10)66500UQ06
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 07P72-20
• Device Lot Number: 66500UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C CO2 RGT 3000T, 07P72-20, 67438UQ12; ALNTY C CO2 RGT 3000T, 07P72-20, 67438UQ12; ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown